Benefit of IQP-VV-102 in Reducing Postprandial Glucose Level in Overweight Caucasian Subjects
9. November 2015 aktualisiert von: InQpharm Group
Double-blind, Randomised, Placebo-controlled, Three-way Crossover Clinical Investigation to Evaluate the Benefit of IQP-VV-102 in Reducing Postprandial Glucose Level in Overweight Caucasian Subjects
In this trial, the investigational product , the active ingredients which has been proven to reduce postprandial glucose in healthy and diabetic patients, will be tested.
The primary aim of this clinical study is to evaluate the possibility of the investigational product to reduce the rise of postprandial glucose AUC level in overweight Caucasian subjects with normal to prediabetic biomarkers (IFG/HbA1C), without prompting a disproportionate rise in insulin levels.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
27
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Berlin, Deutschland, 10369
- analyze & realize GmbH
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 60 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Caucasian
- BMI between ≥ 25 and < 30 kg/m2
- Normal to prediabetic biomarkers: FBG 3.9-6.9 mmol/L / 70-125mg/dL and HbA1c 4-6.4%
- Willing to take test meal and adhere to consumptions of pre-prepared meals supplied (controlled by subject diary)
- Willing to maintain same level of physical activity during the study
- Willing to arrive at the study site with the same, non-strenuous means of transportation during the study
- Negative pregnancy testing (beta hCG) for women of childbearing potential during screening
- Women of child-bearing potential have to agree to use appropriate birth control methods during the study period
- Written informed consent of the subject to participate is a prerequisite for study participation
Exclusion Criteria:
- Known sensitivity to L-arabinose and grape marc extracts, or any sources of the active ingredients and excipients
- Use of medications or dietary supplements that may influence body weight 4 weeks, and gastrointestinal functions 2 weeks prior to enrolment and during the study
- Use of anti-diabetic medication
- Strenuous exercise within one day prior to blood glucose sampling (including screening).
- History of bariatric surgery, small bowel resection, or extensive bowel resection
- Difficult veins
- Recent blood donation in the last 1 month prior to study
- Pregnancy or nursing
- Clinically relevant excursions of safety parameters
- Any other serious condition or disease that renders subjects ineligible
- Smoking
- Exceeding safe alcohol consumption (men: ≥ 21 units/week; women: ≥ 14 units/week) and any alcohol consumption within 24 hours before venous blood glucose sampling
- All vegetarians and subjects with self-reported diet high in fat or protein
- Subjects are not able to communicate with local study staff
- Recent antibiotic and cortisone use up to one week and during the study
- Participation in another study during the last 30 days of the screening visit (V1)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: Dose 1 of IQP-VV-102
Total 4 tablets (2 tablets with active ingredients and 2 placebo tablets) to be taken, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water.
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Dose 1 (D1) group will take 2 tablets with active ingredients and 2 placebo tablets.
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Aktiver Komparator: Dose 2 of IQP-VV-102
Total 4 tablets (4 tablets with active ingredients) to be taken, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water.
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Dose 2 (D2) group will take 4 tablets with active ingredients.
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Placebo-Komparator: Placebo
Total 4 placebo tablets, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water.
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Placebo group will take 4 placebo tablets. The placebo is designed to be identical to IQP-VV-102. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Percentage change in raised postprandial glucose (PPG) AUC levels of the verum groups (dose D1 and dose D2) compared against the placebo among normal to prediabetic overweight Caucasian subjects.
Zeitfenster: 120 minutes
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Measures raised PPG AUC levels (mmol/L) from 0-120 minutes on each visit
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120 minutes
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in incremental PPG AUC level (mmol/L)
Zeitfenster: 120 minutes
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Measured from 0-120 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.
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120 minutes
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Change in total and incremental PPG AUC level (mmol/L)
Zeitfenster: 180 minutes
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Measured from 0th minute, to 60th, 90th and 180th minute after intake of verum or placebo on subjects on each of the 3 visit days.
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180 minutes
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Changes in PPG concentration
Zeitfenster: 180 minutes
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Measured at 15, 30, 45, 60, 90, and 120 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.
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180 minutes
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Dose response of PPG level
Zeitfenster: Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
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Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
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Change in total and incremental AUC insulin level (mmol/L)
Zeitfenster: 180 minutes
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Measured from 0th minute to 120th and 180th minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.
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180 minutes
|
|
Dose response of insulin level
Zeitfenster: Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
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Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
|
|
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Change in total and incremental AUC triglyceride level
Zeitfenster: 180 minutes
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Measured from 0-180 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.
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180 minutes
|
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Global evaluation of tolerability both by investigator and subjects
Zeitfenster: Throughout the study (8-14 days)
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Global scaled evaluation with "very good", "good", "moderate" and "poor"
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Throughout the study (8-14 days)
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Incidence of adverse events (Safety parameters evaluation)
Zeitfenster: Throughout the study period (8-14 days)
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Eg. Liver Function Test, Lipid parameters, Renal Function Tests.
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Throughout the study period (8-14 days)
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Reported adverse events
Zeitfenster: Throughout the whole study period (8-14 days)
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For any adverse event, the term of the event, intensity, duration, seriousness, frequency, outcome and assessment of causality with the investigational product will be documented in the Case Report Form (CRF)
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Throughout the whole study period (8-14 days)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Ralf Uebelhack, PhD, Charite
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Juni 2014
Primärer Abschluss (Tatsächlich)
1. Oktober 2015
Studienanmeldedaten
Zuerst eingereicht
24. August 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
1. September 2015
Zuerst gepostet (Schätzen)
4. September 2015
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
10. November 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. November 2015
Zuletzt verifiziert
1. November 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- INQ/024613
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